EU Biosimilar Filings, Opinions And Approvals
Executive Summary
A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event, is provided in the Pink Sheet's newest Performance Tracker.
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Pfizer/BioNTech’s COVID-19 Vaccine First To Be Approved In Australia
Australia will begin its coronavirus vaccination program with Comirnaty. The Oxford University/AstraZeneca vaccine is expected to be the next to receive approval.
Hungary Breaks Ranks With EU & Authorizes Use Of AstraZeneca Vaccine
Hungary is going its own way when it comes to coronavirus vaccines, but its decision to allow the emergency use of the Oxford University/AstraZeneca vaccine may be only a symbolic expression of the government’s growing impatience with the EU.
Valneva Starts COVID-19 Vaccine Production In Scotland
Valneva is scaling up manufacture of its coronavirus vaccine alongside the clinical development program, with a view to meeting its commitment to provide millions of doses for use in the UK and the EU.
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